Trial Outcomes & Findings for Vitamin D Supplementation in Psychiatric Illnesses (NCT NCT01004354)

NCT ID: NCT01004354

Last Updated: 2017-11-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	Vitamin D This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Supplementation in Psychiatric Illnesses

Baseline characteristics by cohort

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.6 years STANDARD_DEVIATION 1.65 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Change in Weight	0.07 kilograms Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 8 weeks

HOMA-IR:

It is calculated multiplying fasting plasma insulin (FPI) by fasting plasma glucose (FPG), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment Baseline	3.01 HOMA-IR score Standard Deviation 2.65
Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment Final (8 weeks)	2.48 HOMA-IR score Standard Deviation 2.00

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Data were not collected for this analyte.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
HDL-cholesterol at Baseline and Post-treatment Baseline	43.4 mg/dL Standard Deviation 8.75
HDL-cholesterol at Baseline and Post-treatment Final (8 weeks)	39.8 mg/dL Standard Deviation 9.35

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
LDL-cholesterol at Baseline and Post-treatment Baseline	102.00 mg/dL Standard Deviation 23.17
LDL-cholesterol at Baseline and Post-treatment Final (8 weeks)	86.89 mg/dL Standard Deviation 29.60

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Total Cholesterol at Baseline and Post-treatment Baseline	173.67 mg/dL Standard Deviation 21.22
Total Cholesterol at Baseline and Post-treatment Final (8 weeks)	161.33 mg/dL Standard Deviation 20.35

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Triglycerides at Baseline and Post-treatment Baseline	189.7 mg/dL Standard Deviation 176.8
Triglycerides at Baseline and Post-treatment Final (8 weeks)	197.9 mg/dL Standard Deviation 121.31

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Adiponectin at Baseline and Post-treatment Baseline	9.1 mcg/mL Standard Deviation 4.75
Adiponectin at Baseline and Post-treatment Final (8 weeks)	8.9 mcg/mL Standard Deviation 4.7

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Vitamin D n=12 Participants This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
Leptin at Baseline and Post-treatment Baseline	39.23 ng/mL Standard Deviation 22.54
Leptin at Baseline and Post-treatment Final (8 weeks)	43.69 ng/mL Standard Deviation 24.37

Adverse Events

Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin U Nwosu, MD

University of Massachusetts Medical School

Phone: 5083347872

Email: benjamin.nwosu@umassmemorial.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place